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目的对我国药品生产场地变更提供一些建议。方法通过对美国药品生产场地变更法规进行研究,分析美国药品生产变更的制度体系的优势。结果与结论我国应借鉴美国的对生产场地变更的规定,应用风险评估的方法对各类生产变更进行分类,并设置不同监管力度的变更报告申请类型,通过对不同变更申请的审核,加强对高风险场地变更的监管,及时评估场地变更类型的风险程度,减小对风险降低的生产变更的监管力度,从而减轻相关监管机构以及企业的负担;在现有基础上放开对场地变更的限制,促进上市许可制度的顺利实行。
Objective To provide some suggestions on the change of our country’s pharmaceutical production site. Methods Through the research on the change regulations of the drug production sites in the United States, the advantages of the system of drug production changes in the United States were analyzed. Results and Conclusion Our country should learn from the provisions of the United States on the change of production sites, the application of risk assessment methods for classification of various types of production changes, and set different regulatory efforts to change the reporting type of application, through the review of different changes to strengthen the application of high The supervision on the change of the risk field, the timely assessment of the risk level of the site change type, and the reduction of the supervision on the production change with reduced risk so as to reduce the burden on the relevant regulatory agencies and enterprises; and on the existing basis, Promote the smooth implementation of the listing permit system.